During open-heart surgery, a pair of internal defibrillation paddles is used to restart the patient's heart. Each internal defibrillation paddle comprises a handle attached to a shaft attached to a spoon electrode. The paddle handles are held by a surgeon while the spoon electrodes are inserted into the patient's chest and placed in direct contact with the myocardium (heart muscle). An electric discharge is passed from one spoon electrode through the patient's heart to a second spoon electrode.
Prior to use, paddle electrodes must be sterilized to eliminate patient infection. Modern sterilization methods use heat or chemical agents, such as ethylene oxide. The methods and materials used degrade the paddle materials limiting their useful life. Most manufacturers specify a maximum service life for paddles, usually in the range of 50–100 sterilization cycles. However, there is no convenient mechanism for users to measure and track the number of sterilization cycles a paddle experiences. Therefore, there is no easy way to determine if the service life of the paddles has been exceeded.
Sterilization can cause two problems. First, the process is expensive and often uses environmentally unfriendly materials. Second, it is destructive and the expensive reusable paddles must be replaces periodically. Furthermore, it is difficult to pass the cost of the paddle electrodes to the patient because the actual service life is indeterminate.
Paddle cleaning is required after use because dried blood and other dried body fluids must be removed prior to sterilization. Cleaning is time consuming, expensive, and hazardous due to possible contamination with AIDS, Hepatitis, or other infectious materials.
Further, paddles are now made as durable as possible. This means that a paddle electrode contact area is made of thick rigid metal in the shape of a large flat “spoon.” This one-size fits all shape of the spoon is fixed and may not conform equally well to the curvature of all hearts.
Therefore, what is needed is a paddle not subject to the problems indicated above, such as a disposable paddle. What is also needed is a way to test the disposable paddle without comprising the sterility of the paddle.